510(k) · Cleared
ClearedEbi, L.P.'S Line Extension to the Array Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ebi, L.P. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Aug 11, 2006 after a 29-day review. The FDA summary names its predicate without a number. 15 later devices descend from it.
- Decided
- Aug 11, 2006
- Review
- 29 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 1 citing it directly.
- This deviceK061978 Ebi, L.P.'S Line Extension to the Array Spinal SystemEbi, L.P. · 2006
- Descendant · cites it directly · 14 of its ownK122332 Towerlox Pedicle Screw SystemCaptiva Spine · 2012
- Descendant · 2 generations on · 6 of its ownK131538 Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine · 2013
- Descendant · 2 generations on · 5 of its ownK152781 Adena-Zina SystemShanghai Sanyou Medical Co, Ltd. · 2016
- Descendant · 3 generations on · 3 of its ownK212066 Adena-Zina SystemShanghai Sanyou Medical Co, Ltd. · 2021
- Descendant · 3 generations on · 3 of its ownK151116 CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine · 2015
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K122332Towerlox Pedicle Screw SystemCaptiva Spine · 2012 · cites it directly14descendants
- K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine · 2013 · 2 generations on6descendants
- K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd. · 2016 · 2 generations on5descendants
- K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd. · 2021 · 3 generations on3descendants
- K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine · 2015 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061978 | Ebi, L.P.'S Line Extension to the Array Spinal System | Ebi, L.P. | 2006 | — |
| +1 | K122332 | Towerlox Pedicle Screw System | Captiva Spine | 2012 | — |
| +2 | K131538 | Caplox II Pedicle Screw System/Towerlox Pedicle Screw System | Captiva Spine | 2013 | — |
| +2 | K152781 | Adena-Zina System | Shanghai Sanyou Medical Co, Ltd. | 2016 | — |
| +3 | K212066 | Adena-Zina System | Shanghai Sanyou Medical Co, Ltd. | 2021 | — |
| +3 | K151116 | CapLOX II/TowerLOX Pedicle Screw System | Captiva Spine | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MNI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | EBI® Array® Spinal System (formerly referred to as 'Top Loading MAS Spinal Fixation… Named without a submission number | |
| * | — | EBI® Webb Morley Spine System Named without a submission number |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122332 | Towerlox Pedicle Screw System | 2012 | 14 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K122332 (Captiva Spine, 2012) has gone furthest, with 14 descendants of its own.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Array Spinal System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacralliliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use; degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, and/or lordosis), tumor, stenosis, pseudarthirosis, and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061978 · printed Nov 3, 2026
Cite this page
510(k) Report. “K061978: Ebi, L.P.'S Line Extension to the Array Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K061978
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026